INFACOL

PDF Transcript

Simeticone 40 mg per 1 ml Oral Suspension
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important
information for your baby.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– You must contact a doctor if your baby’s symptoms worsen or do not improve.
– If any side effects occur, please tell your doctor or pharmacist.
In this leaflet:
1. What Infacol is and what it is used for
2. Before you give Infacol
3. How to give Infacol
4. Possible side effects
5. How to store Infacol
6. Further information
1. WHAT INFACOL IS AND WHAT IT IS USED FOR
Your baby’s medicine is called Infacol. It is an antiflatulent which
means that it helps to bring up wind or air trapped in the tummy.
Infacol is given to babies to relieve griping pain, infant colic or
wind due to trapped air. It can be given from birth onwards. The
pain associated with colic may be caused by the build-up of small
gas bubbles trapped in your baby’s tummy. Simeticone, the active ingredient in Infacol,
helps all the little trapped gas bubbles join into bigger bubbles which your baby can easily
bring up as wind.
2. BEFORE YOU GIVE INFACOL
Do not give Infacol and get advice from a doctor if your baby is being treated for a thyroid
disorder.
Do not give Infacol if you think your baby might be allergic (hypersensitive) to any of the
ingredients of Infacol (see section 6 of this leaflet).
Using other medicines
If your baby is being treated with levothyroxine for a thyroid disorder using Infacol might
reduce the amount of this type of medicine that is absorbed and weaken the effect of their
treatment.
3. HOW TO GIVE INFACOL
Follow the instructions about when and how to use the product. You should check with
your doctor or pharmacist if you are not sure.
Dose
Infacol is very simple to give, even when your baby is crying. The normal dose is one
dropper full (0.5ml) which should be given before each feed. If after 3 or 4 days your baby’s
colic still seems to be upsetting, you can double the dose to two droppers full (1ml). This
may be especially useful at night, before the evening feed.
Infacol should be used for several days to achieve the best results, as treatment may show a
progressive effect. Continued use may help to prevent a further build up of wind. You can
continue to use Infacol for several weeks. However, if despite having increased the dose to
two droppers full there is no improvement, or your baby seems to be getting worse, speak
to your health visitor or doctor.
Administration
• Gently shake the bottle.
• Draw up one dropper full by squeezing the bulb twice. Let the excess Infacol on the
outside of the dropper run back into the bottle.
AAAH7802

Page 1 of 2
colours/plates

Infacol 40 mg/ml 1x50 ml PIL - UK
item no:

AAAH7802

dimensions: 210 x 160

print proof no:

3

pharmacode:

origination date: 24.03.15

approved for print/date

1. pms 199C

min pt size: 9 pt

originated by:

R.Paul

revision date:

02.04.15

Technical Approval

revised by:

R.Paul

date sent: 23.03.15

supplier:

IL/Laleham
Healthcare

technically app. date: 27.03.15

2. pms 266C
3.
4.
5.
6.
Non Printing Colours
1. Profile/Code Area

• Administer the dose by squeezing the bulb and releasing the Infacol onto the back of
your baby’s tongue.
Do not use the dropper for other medicines. Keep it for Infacol only.
If you give more Infacol than you should
If your baby (or an adult) accidentally swallows a large quantity of Infacol (such as a whole
bottle full) it is highly unlikely to do any harm.
However, if the person who has taken it feels or looks unwell, you should seek medical
advice.
If you forget to give Infacol
Do not worry if you forget to give your baby one or more doses. Simply give the next dose
before the baby’s next feed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Simeticone, the active ingredient in Infacol, is not absorbed into the baby’s body and is very
unlikely to harm your baby. It is very unusual for Infacol to cause any side-effects. Methyl
and propyl hydroxybenzoates (E218, E216), which are also ingredients in Infacol, may cause
allergic reactions (possibly delayed).
Reporting of side effects
If your baby gets any side effects, talk to your doctor, pharmacist or health visitor. This
includes any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. HOW TO STORE INFACOL
Keep out of the reach and sight of children.
Do not use Infacol after the expiry date which is stated on the bottle and carton after the
letters ‘EXP’. The expiry date refers to the last day of that month.
Once opened, use within 28 days. Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Infacol contains
The active ingredient is simeticone at a concentration of 40mg/ml.
The other ingredients are saccharin sodium, hypromellose, orange flavour, methyl
hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and purified water.
What Infacol looks like and contents of the pack
Infacol is an orange-flavoured, off-white, oral suspension (liquid). Each full bottle contains
50ml of Infacol, which is enough for up to 100 doses.
The Marketing Authorisation Holder is
The Manufacturer is
Forest Laboratories UK Ltd.,
Laleham Health and Beauty Ltd
Whiddon Valley, Barnstaple,
Sycamore Park, Mill Lane, Alton
North Devon,EX32 8NS, UK
Hampshire GU34 2PR, UK
This leaflet was last approved in March 2015
To listen to or to request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product Name
Reference Number
Infacol 40mg/ml Oral Suspension
0108/0100
This is a service provided by the Royal National Institute for Blind People
AAAH7802

Page 2 of 2
Infacol 40 mg/ml 1x50 ml PIL - UK
item no:

AAAH7802

dimensions: 210 x 160

print proof no:

3

pharmacode:

origination date: 24.03.15

approved for print/date

1. pms 199C

min pt size: 9 pt

originated by:

R.Paul

revision date:

02.04.15

Technical Approval

revised by:

R.Paul

date sent: 23.03.15

supplier:

IL/Laleham
Healthcare

technically app. date: 27.03.15

2. pms 266C
3.
4.
5.
6.
Non Printing Colours
1. Profile/Code Area

Simeticone 40 mg per 1 ml Oral Suspension
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important
information for your baby.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your baby’s symptoms worsen or do not improve.
- If any side effects occur, please tell your doctor or pharmacist.
In this leaflet:
1. What Infacol is and what it is used for
2. Before you give Infacol
3. How to give Infacol
4. Possible side effects
5. How to store Infacol
6. Further information
1. WHAT INFACOL IS AND WHAT IT IS USED FOR
Your baby’s medicine is called Infacol. It is an antiflatulent which
means that it helps to bring up wind or air trapped in the tummy.
Infacol is given to babies to relieve griping pain, infant colic or
wind due to trapped air. It can be given from birth onwards. The
pain associated with colic may be caused by the build-up of small
gas bubbles trapped in your baby’s tummy. Simeticone, the active ingredient in Infacol,
helps all the little trapped gas bubbles join into bigger bubbles which your baby can easily
bring up as wind.
2. BEFORE YOU GIVE INFACOL
Do not give Infacol and get advice from a doctor if your baby is being treated for a thyroid
disorder.
Do not give Infacol if you think your baby might be allergic (hypersensitive) to any of the
ingredients of Infacol (see section 6 of this leaflet).
Using other medicines
If your baby is being treated with levothyroxine for a thyroid disorder using Infacol might
reduce the amount of this type of medicine that is absorbed and weaken the effect of their
treatment.
3. HOW TO GIVE INFACOL
Follow the instructions about when and how to use the product. You should check with
your doctor or pharmacist if you are not sure.
Dose
Infacol is very simple to give, even when your baby is crying. The normal dose is one
dropper full (0.5ml) which should be given before each feed. If after 3 or 4 days your baby’s
colic still seems to be upsetting, you can double the dose to two droppers full (1ml). This
may be especially useful at night, before the evening feed.
Infacol should be used for several days to achieve the best results, as treatment may show a
progressive effect. Continued use may help to prevent a further build up of wind. You can
continue to use Infacol for several weeks. However, if despite having increased the dose to
two droppers full there is no improvement, or your baby seems to be getting worse, speak
to your health visitor or doctor.
Administration
• Gently shake the bottle.
• Draw up one dropper full by squeezing the bulb twice. Let the excess Infacol on the
outside of the dropper run back into the bottle.
AAAH7809

• Administer the dose by squeezing the bulb and releasing the Infacol onto the back of
your baby’s tongue.
Do not use the dropper for other medicines. Keep it for Infacol only.
If you give more Infacol than you should
If your baby (or an adult) accidentally swallows a large quantity of Infacol (such as a whole
bottle full) it is highly unlikely to do any harm.
However, if the person who has taken it feels or looks unwell, you should seek medical
advice.
If you forget to give Infacol
Do not worry if you forget to give your baby one or more doses. Simply give the next dose
before the baby’s next feed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Simeticone, the active ingredient in Infacol, is not absorbed into the baby’s body and is very
unlikely to harm your baby. It is very unusual for Infacol to cause any side-effects. Methyl
and propyl hydroxybenzoates (E218, E216), which are also ingredients in Infacol, may cause
allergic reactions (possibly delayed).
Reporting of side effects
If your baby gets any side effects, talk to your doctor, pharmacist or health visitor.
This includes any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE INFACOL
Keep out of the reach and sight of children.
Do not use Infacol after the expiry date which is stated on the bottle and carton after the
letters ‘EXP’. The expiry date refers to the last day of that month.
Once opened, use within 28 days. Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Infacol contains
The active ingredient is simeticone at a concentration of 40mg/ml.
The other ingredients are saccharin sodium, hypromellose, orange flavour, methyl
hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and purified water.
What Infacol looks like and contents of the pack
Infacol is an orange-flavoured, off-white, oral suspension (liquid). Each full bottle contains
50ml of Infacol, which is enough for up to 100 doses.
The Marketing Authorisation Holder is
Forest Laboratories UK Ltd.,
Whiddon Valley, Barnstaple,
North Devon EX32 8NS,
UK

This leaflet was last approved in March 2015
To listen to or to request a copy of this leaflet in Braille, large print
or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product Name
Reference Number
Infacol 40mg/ml Oral Suspension
0108/0100
This is a service provided by the Royal National Institute for Blind People
AAAH7809

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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